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SynCardia Systems LLC recalls SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Heart System (50CC): 570500-000
Recalled February 8, 2023 · FDA recall Z-1022-2023 · SynCardia Systems
Hazard
Due to tears reported tears in the cannula due to wear and tear stress. · FDA Class II
Units
1,732 systems
Sold at
Worldwide distribution - U.S. Nationwide distribution in the states of AL, AR, AZ, CA, FL, IA. IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NY, OH, OK, PA, TN, TX, UT, VA, WA, and WI. The countries of Australia, Austria, Canada, Croatia, Finland, France, Germany, Greece, Israel, Italy, Kuwait, Lebanon, Lithuania, Macedonia, Poland, Russia, Saudi Arabia, Serbia, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
Description
Due to tears reported tears in the cannula due to wear and tear stress.
Product
SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Heart System (50CC): 570500-000
Manufacturer(s)
SynCardia Systems LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →